Intervention in Spirituality at the End of Life. The Kibo Protocol

June 25, 2019 updated by: M. Antonia Pérez-Marín, University of Valencia

This work aims to study the benefits that the therapeutic interview Kibo in palliative care patients can have for spirituality.

A parallel randomized controlled trial of two groups was performed. Information was collected on 60 palliative care patients during the moments before and after the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Universitat de València

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. To be 18 or more years of age.
  2. Being in advanced or terminal disease phase (following World Health Organization criteria).
  3. To have preserved cognitive capacity.
  4. To have signed the informed consent.

Exclusion Criteria:

a) Estimated time of survival: Patients with a life expectancy of two weeks or less will not be intervened.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Group of participants that received usual psychological attention.
Experimental: Experimental group
Group of participants that received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
Other: Therapeutic interview: kibo protocol
The kibo protocol is a therapeutic interview designed to address the spiritual needs of patients at the end of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the dimension of spirituality (PRE and POST measures)
Time Frame: Baseline up to 4 weeks

This variable was assessed with the Spirituality questionnaire from the Spanish Society of Palliative Care (SECPAL). This questionnaire contains 8 items, and it provides scores from 0 to 32, where higher values represent a better outcome.

In order to observe the change in the dimension of spirituality, it was measured at in two time points:

First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.

Second measurement: POST. Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out.

Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
Baseline up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in resilience (PRE and POST measures)
Time Frame: Baseline up to 4 weeks

This variable was assessed with the Brief Resilient Coping Scale (BRCS). This scale contains 4 items, and it provides scores from 4 to 20, where higher values represent a better outcome.

In order to observe the change in the dimension of resilience, it was measured at in two time points:

First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.

Second measurement: POST. Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out.

Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
Baseline up to 4 weeks
Change in demoralization (PRE and POST measures)
Time Frame: Baseline up to 4 weeks

This variable was assessed with the Short Demoralization Scale (SDS). This scale contains 5 items, and it provides scores from 0 to 20, where lower values represent a better outcome.

In order to observe the change in the dimension of demoralization, it was measured at in two time points:

First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.

Second measurement: POST. Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out.

Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).
Baseline up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Collaborators

Sociedad Española de Cuidados Paliativos SECPAL

Investigators

  • Principal Investigator: Pilar Barreto Martin, PhD, Universitat de València

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (Actual)

June 21, 2019

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1447334931417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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